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TC-210 Strives To Compose Harmonized QS Device Guidance In Timely Manner

This article was originally published in The Gray Sheet

Executive Summary

ISO 14969:1999 is expected to be revised and issued as a stand-alone technical specification document as a result of the changes that were made in the updated ISO 9000 family of standards.

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International News In Brief

Quality systems technical report: Final version of Technical Report 14969, which provides guidance on device use quality systems standard ISO 13485:2003, is expected by late spring or early summer, BSI Assistant VP-Product Services Paul Brooks tells participants at Regulatory Affairs Professionals Society Principles & Practices of EU Regulatory Affairs meeting Feb. 23-24 in Arlington,Va. TR 14969 previously was a guidance standard, but was changed to a technical report with the update of ISO 13485 (1"The Gray Sheet" July 2, 2001, p. 14). The ISO quality standard will replace its 1996 predecessor in July 2006...

International News In Brief

Quality systems technical report: Final version of Technical Report 14969, which provides guidance on device use quality systems standard ISO 13485:2003, is expected by late spring or early summer, BSI Assistant VP-Product Services Paul Brooks tells participants at Regulatory Affairs Professionals Society Principles & Practices of EU Regulatory Affairs meeting Feb. 23-24 in Arlington,Va. TR 14969 previously was a guidance standard, but was changed to a technical report with the update of ISO 13485 (1"The Gray Sheet" July 2, 2001, p. 14). The ISO quality standard will replace its 1996 predecessor in July 2006...

Technical Report Readied By TC-210 Following Recent ISO Quality Standard

An International Standards Organization technical report expected out by year-end will provide guidance on the recently issued device quality management standard ISO 13485

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